Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

This study has been terminated.
(Closed due to insufficient recruitment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234468
First received: October 5, 2005
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy


Condition Intervention Phase
Non Small Cell Lung Carcinoma
Drug: Iressa (Gefitinib)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to progression (2 years after Last patient in)

Secondary Outcome Measures:
  • Modalities of relapse or progression (2 years after Last patient in)
  • Overall survival (2 years after Last patient in)

Estimated Enrollment: 490
Study Start Date: January 2004
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically Confirmed Non Small Cell Lung Cancer.
  • Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
  • Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
  • Response to combined therapy

Exclusion Criteria:

  • No previous treatment with ZD1839 or any other EGFR-targeted therapy
  • No progressive disease after combined therapy for locally advanced NSCLC
  • No presence of metastatic disease
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity from previous anticancer therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234468

Locations
Italy
Research Site
Avellino, Italy
Research Site
Bergamo, Italy
Research Site
Bologna, Italy
Research Site
Cagliari, Italy
Research Site
Campobasso, Italy
Research Site
Catania, Italy
Research Site
Catanzaro, Italy
Research Site
Chieti, Italy
Research Site
Cosenza, Italy
Research Site
Della Fratte, Italy
Research Site
Emilia, Italy
Research Site
Fano, Italy
Research Site
Firenze, Italy
Research Site
Forli, Italy
Research Site
Frattamaggiore, Italy
Research Site
Livorno, Italy
Research Site
Messina, Italy
Research Site
Milano, Italy
Research Site
Napoli, Italy
Research Site
Novara, Italy
Research Site
Orbassano, Italy
Research Site
Padova, Italy
Research Site
Palermo, Italy
Research Site
Pavia, Italy
Research Site
Potenza, Italy
Research Site
Ravenna, Italy
Research Site
Rimini, Italy
Research Site
Roma, Italy
Research Site
San Giovanni Rotondo, Italy
Research Site
Sassari, Italy
Research Site
Taormina, Italy
Research Site
Venezia-Mestre, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lucio Crino, MD Bologna Italy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234468     History of Changes
Other Study ID Numbers: 1839IL/0126
Study First Received: October 5, 2005
Last Updated: May 19, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by AstraZeneca:
Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014